>FDA URGENT INFORMATION
>Recall of Clinipad Sterile Products Used in
>Prepackaged Procedure Kits and Trays
>(You are encouraged to copy and distribute this information)
>
>
>March 29, 2000
>
>To:
>Hospital Administrators
>Risk Managers
>Director, Central Supply
>Ambulatory Surgery Centers
>Dialysis Centers
>
>I am writing to let you know that certain prepackaged procedure kits and
>trays may include sterile antiseptic skin preparations that have been
>recalled by Clinipad Corporation because they may not be sterile. More than
>140 manufacturers prepare a variety of procedure kits and trays that include
>one or more of these recalled products.
>
>Recommendations
>
>- Do not use any recalled Clinipad Corporation products.
>
>- You should be receiving Urgent Device Recall letters from the
>manufacturers of affected procedure kits and trays used in your facility.
>Each manufacturer may handle the recall of their kits and trays differently.
>Follow the directions provided by each manufacturer for their kits and
>trays. Even if the kit or tray manufacturer does not contact you, you still
>should not use any of the
>recalled Clinipad products. Keep in mind that unless stated otherwise by
>the manufacturer, only the Clinipad product from each kit or tray is being
>recalled.
>
>- If you assemble custom kits for use in your facility, be sure to remove
>all recalled products from these kits.
>
>Clinipad Corporation Products Included in the Recall
>
>The nationwide recall of the Clinipad sterile-products line includes
>Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol and
>Alcohol Antiseptic Products as well as Sterile Cliniguard Protective
>Dressing labeled as "sterile." The recall includes all such products
>manufactured since January 1, 1997. The products
>(swabsticks, prep pads, towelettes, ointment tubes and pouches, and
>protective dressings) are distributed under the names: Cliniswab, Clinipad,
>Clinidine, Cliniguard, EZ Prep, Cooper Instrument Corp., Moore Medical
>Corp., and Rauscher. They are sold separately or packaged in various
>manufacturer prepared procedure
>kits and trays and are widely distributed to blood banks, hospitals,
>clinics, and retail pharmacies. They are used to prepare the skin prior to
>invasive procedures.
>
>All lots of the sterile products involved in the recall have a lot number
>beginning with 7, 8, 9, or 0, and are labeled as "sterile" or "sterile
>unless opened or damaged" on the unit of use packaging.
>
>Reason for the Recall
>
>The reason for the Clinipad Corporation recall is that the company has
>confirmed bacterial contamination in some lots of its sterile products,
>including one lot with Pseudomonas aeruginosa, Stenotrophomonas maltophilia,
>and coagulase negative
>Staphylococcus, and therefore cannot assure the sterility of its products
>labeled and sold as sterile. These organisms can cause skin, wound, or
>other infections that may be serious or life threatening in some cases.
>
>Additional Information
>
>For facilities whose current procedure includes the use of the recalled
>prepackaged products, FDA's Center for Biologics Evaluation and Research has
>posted information on its web site regarding methods and products that may
>be used for skin preparation prior to the collection of blood and blood
>components. The web address is http://www.fda.gov/cber/infosheets.htm.
>
>Additional information regarding these recalls can also be found on the
>FDA's MedWatch web site at
>http://www.fda.gov/medwatch/safety/2000/safety00.htm.
>
>The Clinipad Corporation can be contacted at 860-571-0100.
>
>Questions regarding this letter can be e-mailed to phann@cdrh.fda.gov; faxed
>to Ms. Marian Zellner at 301-594-2968; or submitted in writing to Ms.
>Zellner at FDA, CDRH, Office of Surveillance and Biometrics, HFZ-510, 1350
>Piccard Drive,
>Rockville, MD 20850.
>
>Additional copies of this notification, as well as all of FDA's medical
>device postmarket safety notifications, can be found on the FDA web site at
>http://www.fda.gov/cdrh/safety.html. Postmarket safety notifications can
>also be obtained through e-mail on the day they are released by subscribing
>to our list server. To subscribe, send a message to
>fdalists@archie.fda.gov. In the body of the
>text, type subscribe dev-alert.
>
>Reporting Adverse Events
>
>FDA solicits your help in collecting data on adverse events related to
>medical devices. Healthcare professionals employed by healthcare facilities
>that are subject to FDA's user facility reporting requirements should follow
>the reporting procedures established by their facility. Practitioners can
>also report incidents directly to MedWatch, the FDA's voluntary reporting
>program. The reports can be submitted
>by phone at 800-FDA-1088; by fax at 800-FDA-0178; via the MedWatch web site
>at http://www.fda.gov/medwatch; or by mail to MedWatch, FDA, HF-2, 5600
>Fishers Lane, Rockville, MD 20857.
>
>Sincerely yours,
>
>David W. Feigal, Jr., MD, MPH
>Director,
>Center for Devices and Radiological Health
>